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What is Bravelle?

What does Bravelle look like?

What are the available doses of Bravelle?

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What should I talk to my health care provider before I take Bravelle?

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How should I use Bravelle?

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What interacts with Bravelle?

  • Bravelle is contraindicated in women who have:

    • A high FSH level indicating primary ovarian failure.
    • Uncontrolled thyroid and adrenal dysfunction.
    • An organic intracranial lesion such as pituitary tumor.
    • The presence of any cause of infertility other than anovulation.
    • Abnormal bleeding of undetermined origin.
    • Ovarian cysts or enlargement not due to polycystic ovary syndrome.
    • Prior hypersensitivity to urofollitropins, purified.
    • Bravelle is contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. There are limited human data on the effects of Bravelle when administered during pregnancy.

What are the warnings of Bravelle?

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Overstimulation of the Ovary During Bravelle Therapy

Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distension and/or abdominal pain occurs in approximately 20% of those treated with follitropin and hCG, and generally regresses without treatment within two or three weeks.

In order to minimize the hazard associated with the occasional abnormal ovarian enlargement, which may occur with FSH - hCG therapy, the lowest dose consistent with expectation of good results should be used. Careful monitoring of ovarian response can further minimize the risk of overstimulation.

If the ovaries are abnormally enlarged on the last day of Bravelle therapy, hCG should not be administered in the course of therapy; this will reduce the chances of development of the Ovarian Hyperstimulation Syndrome.

OHSS: OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS may progress rapidly to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. The following symptomatology has been seen with cases of OHSS: abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events (see "" below). Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with the Ovarian Hyperstimulation Syndrome (OHSS).

In a clinical study of ovulation induction, 6 of 72 (8.33%) Bravelle treated women developed OHSS and two were classified as severe. In a clinical study for multiple follicular development during IVF, 3 of 60 Bravelle treated women developed OHSS and 1 was classified as severe. Cases of OHSS are more common, more severe and more protracted if pregnancy occurs. OHSS develops rapidly; therefore patients should be followed for at least two weeks after hCG administration. Most often, OHSS occurs after treatment has been discontinued and reaches its maximum at about 7 to 10 days after treatment. Usually, in cases where OHSS may be developing prior to hCG administration (see ), the hCG should be withheld.

If severe OHSS occurs, treatment be stopped and the patient should be hospitalized.

A physician experienced in the management of the syndrome, or who is experienced in the management of fluid and electrolyte imbalances should be consulted.

Pulmonary and Vascular Complications

Serious pulmonary conditions (e.g. atelectasis, acute respiratory distress syndrome) have been reported. In addition, thromboembolic events both in association with, and separate from, the Ovarian Hyperstimulation Syndrome have been reported following FSH therapy. Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or the extremities. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, pulmonary complications and/or thromboembolic events have resulted in death.

Multiple Pregnancies

Multiple pregnancies have occurred following treatment with Bravelle SC and IM.

Pregnancy outcomes in a controlled study of 72 patients undergoing ovulation induction with Bravelle are shown in Table 4.

The pregnancy outcomes in a controlled study of 60 patients undergoing treatment with Bravelle in IVF are shown in Table 5.

The patient and her partner should be advised of the potential risk of multiple births before starting treatment.

Hypersensitivity/Anaphylactic Reactions Hypersensitivity/anaphylactic reactions associated with follitropins for injection, purified administration have been reported in some patients. These reactions presented as generalized urticaria, facial edema, angioneurotic edema, and/or dyspnea suggestive of laryngeal edema. The relationship of these symptoms to uncharacterized urinary proteins is uncertain.

Table 4. FPI FSH 99-03 Outcome of Pregnancies
Bravelle SCBravelle IM
Total Continuing Pregnancies9(100)7(100)
Total No. with MultiplePregnancies6(66.7)2(28.6)
Table 5. FPI FSH 2001-01 Outcome of Pregnancies
Parameter (%)N(%)
Total No. of Continuing Pregnancies23(100)
Singlets15 (65.2)
Total No. of Multiple Pregnancies8 (34.8)

What are the precautions of Bravelle?


Careful attention should be given to the diagnosis of infertility in the selection of candidates for Bravelle therapy (see ")

Information for Patients

Prior to therapy with Bravelle patients should be informed of the duration of treatment and the monitoring of their condition that will be required. Possible adverse reactions (see section) and the risk of multiple births should also be discussed.

Laboratory Tests

The combination of both estradiol levels and ultrasonography are useful for monitoring the growth and development of follicles, timing hCG administration, as well as minimizing the risk of the Ovarian Hyperstimulation Syndrome and multiple gestations.

The clinical confirmation of ovulation, is determined by:

a. A rise in basal body temperature,b. Increase in serum progesterone, andc. Menstruation following the shift in basal body temperature.

When used in conjunction with indices of progesterone production, sonographic visualization of the ovaries will assist in determining if ovulation has occurred. Sonographic evidence of ovulation may include the following:

a. Fluid in the cul-de-sac, b. Ovarian stigmata, and c. Collapsed follicle.

Because of the subjectivity of the various tests for the determination of follicular maturation and ovulation, it cannot be overemphasized that the physician should choose tests with which he/she is thoroughly familiar.

Carcinogenesis and Mutagenesis

Long-term toxicity studies in animals and in vitro mutagenicity tests have not been performed to evaluate the carcinogenic potential of urofollitropin for injection, purified.


Pregnancy Category X:

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Bravelle, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Patients

Safety and effectiveness in pediatric patients have not been established.

Geriatric Patients

Safety and effectiveness in geriatric patients have not been established.

What are the side effects of Bravelle?

The safety of Bravelle was examined in four clinical studies that enrolled a total of 222 patients receiving Bravelle including 72 for ovulation induction and 150 for IVF.

All adverse events (without regard to causality assessment) occurring ≥ 2 % incidence in the clinical study patients receiving Bravelle are listed in Table 6, (FPI FSH 99-03 study for ovulation induction) and Table 7 (FPI FSH 99-04, FPI FSH 99-­05 and FPI FSH 2001-01 studies for IVF).

Table 6. FPI FSH 99-03 Ovulation Induction Safety Profile
Adverse Events(%)Bravelle SCBravelle IM
Vaginal Hemorrhage3(8.6)0(0.0)
Ovarian Disorder (Pain, Cyst)1 (2.9)3(8.1)
Urinary tract infection01 (2.7)
Cervix disorder1 (2.9)0
Nausea2 (5.7)0(0.0)
Enlarged Abdomen1 (2.9)1 (2.7)
Abdominal Pain1 (2.9)2 (5.4)
Vomiting01 (2.7)
Constipation01 (2.7)
Diarrhea01 (2.7)
Dehydration01 (2.7)
Weight gain1 (2.9)0
Acne1 (2.9)0
Exfoliative dermatitis01 (2.7)
Other Body Systems
Neck pain01 (2.7)
Respiratory Disorder2 (5.7)0 (0.0)
Hot Flashes2(5.7)0(0.0)
Fever01 (2.7)
Hypertension01 (2.7)
Emotional lability01 (2.7)
Depression01 (2.7)
Accidental injury01 (2.7)
Table 7. Integrated IVF Safety Profile
Adverse Events (%)Bravelle SCN=150
Vaginal hemorrhage7(4.7)
Post retrieval pain12(8.0)
Pelvic pain/cramps10.(6.7)
Uterine spasms4(2.7)
Vaginal spotting4(2.7)
Urinary tract infection5 (3.3)
Ovarian disorder3(2.0)
Breast tenderness3 (2.0)
Vaginal Discharge4(2.7)
Infection fungal3 (2.0)
Abdominal cramps21(14.0)
Abdominal pain7(4.7)
Abdominal fullness/enlargement10(6.7)
Other Body Systems
Headache19 (12.7)
Respiratory disorder6 (4.0)
Injection site reaction6(4.0)
Hot flash6(4.0)
Emotional lability3(2.0)

            The following medical events have been reported subsequent to pregnancies resulting from gonadotropin therapy in published clinical studies:

                      The following adverse reactions have been previously reported during urofollitropin for injection, purified therapy:

                      What should I look out for while using Bravelle?

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                      What might happen if I take too much Bravelle?

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                      How should I store and handle Bravelle?

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                      Clinical Information

                      Chemical Structure

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                      Clinical Pharmacology

                      Non-Clinical Toxicology


                      This information is obtained from the National Institute of Health's Standard Packaging Label drug database.

                      While we update our database periodically, we cannot guarantee it is always updated to the latest version.



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